Post by peppy on Dec 12, 2016 8:11:17 GMT -5
Mn, For what its worth regarding the below quote I lifted from your above post, I recall Ray saying they were expecting to hear approval of label change (not a decision on label change) from the FDA in 4th Q 2017 as I recall. I actually posted about this as I thought it was either a slip or a very confident prognosis. They are in communication with FDA about the label change which has now been submitted so perhaps the strategy is to maintain price while they wait for the label change which puts AFREZZA in the class by itself that it deserves. Just a thought as I do not know more than this.
As long as I'm bitching, let me throw this thought out there for everyone to chew on. CEO Pfeffer seemed elated when it was announced that MannKind has submitted an application that the Afrezza label upgraded to ultra fast-acting. That's terrific, but here's the issue for me: what happens if, after another ten months of waiting, the FDA rejects MannKind's label submission?
Read more: mnkd.proboards.com/thread/6734/abc-news?page=2#ixzz4R3TxQptT
Mannmade, I take what you say very seriously. Data in hand, I do not know how the FDA would not make the distinction between fast acting and ultra fast acting.
I see what you mean, will FDA make a new category? A new category will be required.
Until this every moment, I assumed a slam dunk. I also thought there was a good chance it would be approved prior to the 10 month window end which I calculated as june.
www.mannkindcorp.com/Collateral/Documents/English-US/Baughman%20poster%20100-LB%20FINAL%20X2.pdf